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Sunday, April 20, 2008

Medical Ghostwriting Revelations Touch Off Ethics Debate

The latest insult piled onto all the injury inflicted by the Vioxx debacle is disclosed in an article published by the Journal of the American Medical Association last week: Much of the research backing up manufacturer Merck's claims about the drug was ghostwritten by writers in Merck's employ and then rubber-stamped by medical professionals who had little or not involvement in the studies but were willing to attach their names as authors nonetheless.

Though the information came to light in connection with lawsuits over Vioxx, the practice is not unique to Merck. Ghostwriting medical research is common in the pharmaceutical industry, according to many insiders.

The standard should be clear for any scientist asked to lend name and credentials to an article, says Ruth Faden, director of the Hopkins bioethics institute, in an article published by BaltimoreSun.com.

"If I have not contributed in a significant intellectual way to the science being reported or the review of analysis being reported, then I ought not be an author of that manuscript," said Faden. That seems to be a monumental understatement. Taking credit for the work of another has an unsavory name in academic circles. It's called "plagiarism," and it can earn a student a failing grade -- or expulsion.

Journalists who fail to properly attribute sources can lose their jobs and irreparably damage their reputations. Yet, call it "ghostwriting," and the same shameful and deceitful practice suddenly takes on an aura of respectability -- and lines the pockets of the people involved.

If it were merely dishonest, it would be one thing. In the case of medical research, however, the lives of others are at stake.

The issue has taken on graver importance because the US Food and Drug Administration is considering whether to allow the dissemination of articles that appear in peer-reviewed journals to physicians as tools to guide them in deciding whether or not to prescribe a particular drug to a patient for an off-label use.

The bottom line is that virtually everything published about a particular drug could originate with the manufacturer. The new FDA proposal requires that articles published in peer-reviewed journals not be misleading, according to The New York Times.

It strikes me as both appalling and sad that such a requirement should have to be articulated. -dailynews